French Assessment of the Relay Plus and Relay NBS Plus Thoracic Stent-Graft

Vascutek

Status: Completed

Conditions: Pathology of the Thoracic Aorta; Aneurysm Thoracic; Pseudo-aneurysm, Thoracic; Rupture of the Isthmus; Intramural Haematoma of Thoracic Aorta; Dissection of Thoracic Aorta; Penetrating Ulcer of Aorta (Disorder)

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05030740

EFER

Details and patient eligibility

About

Stent treatment of thoracic aortic pathologies, including aneurysms, pseudo-aneurysms, dissections, intramural hematomas, penetrating ulcers and ruptures of the isthmus, seems to provide a likely benefit compared to surgery in terms of surgical mortality and severe morbidity. However, the data concerning the long-term fate of these stents are insufficient. For this reason, the French National Health Authority (HAS) requests a 5-year follow-up in relation to the renewal of insurance reimbursement for these stent-grafts. Therefore, this long-term observational study has been set up.

Full description

Study outline:

French observational, prospective, multi-center, non-randomized, single arm and open-label study.

Study device:

RELAY PLUS and RELAY NBS PLUS thoracic aortic stent or future range extension models, excluding custom-made devices.

A total of 160 patients will be included in France consecutively from all participating centers and among users of the studied stent-graft (all of the centers) or any new center during the inclusion period. The patient will be considered as included in the study when the RELAY PLUS or RELAY NBS PLUS stent-graft is introduced via the surgical or percutaneous approach and provided that the patient meets all of the study eligibility criteria.

The primary endpoint of this study is the 5-year mortality rate (all causes). The objective will be to assess the interest of the technique in terms of the long-term efficacy and safety of the use of the RELAY PLUS or RELAY NBS PLUS stent-graft (i.e. at 5 years) on a cohort of patients representative of the population treated under actual conditions of use.

The implantation of the RELAY PLUS or RELAY NBS PLUS thoracic aortic stent-graft must be carried out in accordance with recommendations issued by the Haute Autorité de Santé (HAS) including:

• Carrying out the implantation in centers with expertise in both endovascular and surgical treatments, and with an adequate technical platform.
• The implementation of a multidisciplinary discussion, in particular on the risk of surgical conversion and the possible use of cardiopulmonary bypass (CPB).
• Verification of the presence of a proximal neck of at least 2 cm in length, allowing for the stent to be placed.
• The need to educate patients about the advantages and disadvantages of the repair techniques available, such as open surgery and endo-aortic stent (EAS).
• Annual monitoring by CT-scan with contrast, or MRI + x-ray.

As this study is observational, no specific examination or procedure outside the framework of the current practice of each center is required.

A summary report will be submitted annually to the Haute Autorité de Santé (HAS). The final report was submitted on 31July2024

Enrollment: 170 patients

Sex: All

Ages: Under 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient requiring the placement of the RELAY PLUS or RELAY NBS PLUS thoracic aortic stent-graft for the treatment of a pathology of their descending thoracic aorta.
• Patient (or legal representative for minor patients) who does not object (in writing or verbally) to the collection and transmission of their data.

Exclusion criteria

• Patients for whom clinical follow-up is not possible, i.e. patients who are unable to return for follow-up visits (for example patients living abroad).
• Patient who earlier benefited from one or more thoracic stent-grafts and for whom a specific follow-up of the RELAY PLUS or RELAY NBS PLUS stent-graft would not be possible depending on the nature of their treatment (e.g. patient already treated with stent-graft in the descending and/or thoraco-abdominal aorta with several extensions) .